Israel FDA 510(k) Overview
Leading Israel FDA 510(k) manufacturers include Card Guard Scientific Survival , Ltd., Aidoc Medical , Ltd., Syneron Medical, Ltd. and 476 others.
Israeli medical device manufacturers have submitted 1,476 FDA 510(k) notifications since 1982, achieving a 98.2% clearance rate across 479 manufacturers. Israel represents one of the most active medtech ecosystems relative to market size, with particular concentration in cardiovascular devices, neurology and advanced diagnostic imaging technologies.
Active in FDA 510(k) submissions since 1982. Many Israel manufacturers work with FDA regulatory consultants to support U.S. market entry.